MYOMA DRILL 5MM-8383.611— 510(k) K940844

Substantially Equivalent

Richard Wolf Medical Instruments Corp.

FDA 510(k) clearance K940844 for MYOMA DRILL 5MM-8383.611, Substantially Equivalent on 1994-05-02. Applicant: Richard Wolf Medical Instruments Corp..

Clearance details

Applicant: Richard Wolf Medical Instruments Corp.
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 1994-02-23
Decision date: 1994-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vernon Hills, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HET

product code HET

Malfunction: 10,504
Total: 10,504

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.